Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. Regenerative medicine also empowers scientists to grow tissues and organs in the laboratory and safely implant them when the body cannot heal itself. Importantly, regenerative medicine has the potential to solve the problem of the shortage of organs available for donation compared to the number of patients that require life-saving organ transplantation, as well as solve the problem of organ transplant rejection, since the organ's cells will match that of the patient (Mason C, Dunnill P (January 2008). “A brief definition of regenerative medicine”. Regenerative Medicine 3 (1): 1-5). The basis of regenerative medicine is the ability of stem cells to grow into various tissues or organs. Embryonic stem (ES) cells are pluripotent cells capable of both proliferation in cell culture and differentiation towards a variety of lineage-restricted cell populations that exhibit multipotent properties (Odorico et al., Stem Cells 19:193-204 (2001)). Because of these characteristics, ES cells, including human ES cells, can become very specific cell types that perform a variety of functions.
While hESC hold great promise for regenerative medicine, obstacles such as prolonged exposure to animal products in culture medium, teratoma formation, and potential need for immunosuppression remain significant safety issues to clinical hESC use.
The embodiments below address the above problems and needs.